Recall Z-2179-2017— GE Healthcare, LLC
Class II · Terminated
Class II FDA medical device recall by GE Healthcare, LLC, initiated 2017-02-06, terminated 2018-03-02. It names 6 FDA 510(k) clearances: K081091, K011624, K973039 and 3 more. Product: Table Patient Step on RFX/SFX, Legacy, and Precision 500D systems. Reason: Reported incidents of a patient step detaching from the table. A fall from a patient step detaching while in use could result in an injury to a patient or operator..
- Recalling firm
- GE Healthcare, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-02-06
- Terminated
- 2018-03-02
- Firm location
- Waukesha, WI, United States
510(k) clearances named in this recall
6 on FDA's record- K081091 — PRECISION 500D R&F X-RAY SYSTEM
- K011624 — EXPEDIO 500D R&F X-RAY SYSTEM
- K973039 — LEGACY/LEGACY-D TABLE
- K862120 — SCX SYSTEM
- K801320 — SFX-90 TABLE/SPOTFILMER W/FLUORICON L200
- K760466 — TABLE, X-RAY, RFX CLASSICAL
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Table Patient Step on RFX/SFX, Legacy, and Precision 500D systems
Reason for recall
Reported incidents of a patient step detaching from the table. A fall from a patient step detaching while in use could result in an injury to a patient or operator.
Data sourced from openFDA. This site is unofficial and independent of the FDA.